Assay Method (K)

Assay Method of

Ketoconazole Tablet

Method - 01

Standard	Prepare standard in the same way  as sample preparation .Conc. 0.002 %  ketoconazole RS in methanol
Sample	Weigh  and powder 20 tablets. To a quantity of  powder containing 50 mg of Ketoconazole add  80 ml of methanol and shake for 25 minutes , add sufficient methanol to  produce 100 ml . Mix and filter. Dilute 2 ml of the filtrate to 50 ml with the same solvent Measure the absorbance at 244 nm , against methanol as reagent blank .

Method - 02

Sample

Weigh and powder 20 tablets. Dissolve powder equivalent  to 200 mg of Ketoconazole in a 100 ml of glacial acetic acid which is previously neutralized with 0.1 N Perchloric acid by using crystal violet solution. Titrate with 0.1 N Perchloric acid VS each ml of 0.1N Perchloric acid VS is equivalent to 26.57 mg of Ketoconazole. % of  content       =  No. of ml of 0.1N Perchloric acid x F x 26.57 X 100 / 200

Assay Method of

Ketorolac Tromethamine Tablet & Injection

Solvent	Water
Standard	60 mg ---® 100 ml ---® take 2 ml ---® 100 ml (Shake 15 minutes)
Sample	Same as standard, Wave Length – 322 nm

Assay Method of

Ketotifen  Tablet & Syrup

Sample

Take powdered sample equivalent to about 1 mg of Ketotifen in a 100ml volumetric flask. Add 60ml of 0.1M Hydrochloric acid. Shake for 20 minutes and add sufficient 0.1M Hydrochloric acid to produce 100 ml. Mix and filter. Measure the absorbance of the resulting solution at the maximum at 297 nm.Calculate the content of Ketotifen taking 475 as the value of A (1%, 1cm ) at the maximum at 297 nm, taking  0.1M Hydrochloric acid in the reference cell % of content = Absorbance of Sample x 100 / Concentration of Sample x 475